The Association Between Interleukin-7 Receptor Gene Polymorphism and the Risk of Ulcerative Colitis

Second Affiliated Hospital of Wenzhou Medical University

Status and phase: Completed; Phase 4

Conditions: Ulcerative Colitis (UC)

Treatments: Biological: Vedolizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT07398586

SAHoWMU-CR2025-01-130

Details and patient eligibility

About

From January 2020 to December 2024, diagnosed ulcerative colitis(UC) patients and gender- and age-matched normal controls were enrolled from the Department of Gastroenterology, the Second Affiliated Hospital of Wenzhou Medical University. Investigators' aim is to investigate the associations of IL-7R gene polymorphisms with the risk and clinicopathological characteristics of UC, and to analyze the effects of IL-7R gene variations on the clinical response of vedolizumab(VDZ) treatment in UC patients.

Full description

From January 2020 to December 2024, diagnosed UC patients and gender- and age-matched normal controls were enrolled from the Department of Gastroenterology, the Second Affiliated Hospital of Wenzhou Medical University. Genotypes of IL-7R were determined by multiplex polymerase chain reaction-ligase detection reaction technique. Chi-square test and unconditional logistic regression model were used to analyze the difference in distribution of IL-7R gene polymorphisms between UC group and normal control group, as well as the effects of IL-7R gene variations on the clinicopathological characteristics and 14-week clinical response to VDZ treatment of participants.

Enrollment: 898 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

-diagnosed UC based on comprehensive clinical, colonoscopy, histopathological, laboratory, and radiographic examination results

Exclusion criteria

-rheumatoid arthritis, systemic lupus erythematosus, intestinal tuberculosis, ischemic enteritis, radiation enteritis, tumors, etc.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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898 participants in 2 patient groups

UC patients

Experimental group

Description:

Some UC patients received intravenous injection of VDZ (300mg/time) at weeks 0, 2, and 6, followed by intravenous injection of the same dose of VDZ every 8 weeks to maintain treatment.

Treatment:

Biological: Vedolizumab

normal control

No Intervention group

Description:

no biological agents treatment